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Completed

NCT Number: NCT06094361

"IONTOPHORESIS vs. PHONOPHORESIS" for Treatment of Subacromial Impingement Syndrome

The aim of this study was to compare the effects of iontophoresis and phonophoresis applications added to conventional treatment on pain, range of motion, disability, and functional status in the shoulder region in patients with subacromial impingement syndrome.

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Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Impingement Syndrome Shoulder Injuries Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34083, Turkey (Türkiye)

About this study

Randomization: Forty-seven patients were assessed, and 43 completed the study in this randomized trial. The participants were divided into two groups (Iontophoresis:22 and Phonophoresis:21) using the online randomization software (www.randomizer.org). All patients gave written informed consent after being verbally informed about the study.

Assessment Period: Assessments were conducted twice, at the start and after completion of the 10-session treatment program.

Session Period: All treatment programs were delivered five days per week for two weeks. The total number of sessions was ten.

Analysis: The statistical analysis was performed using version 21 of the Statistical Package for the Social Sciences (SPSS).To verify normal distribution, the Shapiro-Wilk test and histogram curves were utilized. Descriptive statistics for parametric variables included mean, standard deviation, and percentage. Since the data exhibited normal distribution, independent sample T-tests were used for group comparison while paired sample T-tests were used to detect changes within the group. The significance level of p<0.05 was deemed acceptable for all analyses. For variables with nominal assessments, data were analyzed utilizing Yates Continuity Correction and Fisher's exact chi-square test.

The post hoc power of the study was calculated using Gpower 3.1.9.1 software. The resting VAS scores was taken as reference. In this context, Cohen's effect size was calculated as 1.00. When the alpha error was accepted as 5%, and effect size was 1.00, the post hoc power was found to be 94.27%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with Stage I-II SIS
  • The ages between 18 and 65 years

Exclusion criteria

  • Having underwent shoulder surgery,
  • Participated in a shoulder-related treatment program within the previous six months,
  • Failed to adhere to the treatment program by 70% or more

Treatment and study plan

Iontophoresis Intervention

Procedure

Iontophoresis was applied with a Chattanooga Physio (DJO Global, Herentals, Belgium) brand device. The galvanic current mode was selected for the intervention. Intervention area was cleaned to prevent irritation and active electrode pad (cathode-5 cm2) was immersed in 75 mg diclofenac sodium solution. The current intensity of the application for 10 minutes was 0.1-0.2 mA/cm2.

Phonophoresis

Procedure

Phonophoresis was performed with a Chattanooga brand ultrasound device (Chattanooga, Intelect Legend Ultrasound, TN, USA). 75 mg gel containing 1% diclofenac sodium was applied to the shoulder area. The ultrasound was conducted continuously for 6 minutes with frequency of 1 MHz and an intensity of 1.5 watts/cm2.

Conventional Therapy

Procedure

All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.

Primary outcomes

  1. Visual Analog Scale

    Time frame: At the baseline

    This scale assess the pain of the patients. The scale is scored from 0-10, with 0 indicating no pain and 10 indicating intolerable pain.

  2. Visual Analog Scale

    Time frame: Immediately after 10 physiotherapy sessions on consecutive days

    This scale assess the pain of the patients. The scale is scored from 0-10, with 0 indicating no pain and 10 indicating intolerable pain.

Secondary outcomes

  1. Sociodemographic Data Form

    Time frame: At the baseline

    It is a form containing the descriptive characteristics of the patients.

  2. Range of Motion

    Time frame: At the baseline

    The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.

  3. Range of Motion

    Time frame: Immediately after 10 physiotherapy sessions on consecutive days

    The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.

  4. Shoulder Disability Questionnaire

    Time frame: At the baseline

    This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints

  5. Shoulder Disability Questionnaire

    Time frame: Immediately after 10 physiotherapy sessions on consecutive days

    This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints

  6. Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire

    Time frame: At the baseline

    In the scale, the functional status of individuals with shoulder pathology is questioned during their daily activities, and it is an assessment form filled by the patients themselves.

  7. Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire

    Time frame: Immediately after 10 physiotherapy sessions on consecutive days

    In the scale, the functional status of individuals with shoulder pathology is questioned during their daily activities, and it is an assessment form filled by the patients themselves.

Sponsors and collaborators

Lead sponsor

Emre Şenocak

Other

Registry information

Official study title

"IONTOPHORESIS vs. PHONOPHORESIS": WHICH IS A BEST WAY TO TREAT SUBACROMIAL IMPINGEMENT SYNDROME? A RANDOMIZED STUDY

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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